Food And Drug Administration

FEATURED ARTICLES ABOUT FOOD AND DRUG ADMINISTRATION - PAGE 3

The Food and Drug Administration is accepting public comment at least through February on the safety and effectiveness of saline breast implants. The FDA will amend a proposal requiring manufacturers to submit proof of the safety of saline implants as a condition of keeping them on the market. The saline breast implants have been suggested as an alternative to silicone implants. However, the FDA has received numerous reports of rupture, leakage and deflation associated with saline implants.

WASHINGTON, May 8 (Reuters) - Gilead Science Inc's Truvada may prevent HIV infection among high-risk individuals, if used in combination with other health strategies, and is well-tolerated by individuals who have not contracted the virus that causes AIDS, U.S. Food and Drug Administration review documents said on Tuesday. (Reporting By David Morgan, editing by Dave Zimmerman)

A study of silcone gel breast implants involving two national groups of 5,000 women each will begin in about six months. Dennis Condon, spokesman for Mentor Corp. in Santa Barbara, Calif., a manufacturer of the implants and the only company approved by the Food and Drug Administration to conduct the studies, says one group will receive the implants for reconstructive reasons and the other for cosmetic reasons. Patients will be monitored "intensely for three to five years," says Condon.

New, once-a-day eyedrops that control glaucoma have been licensed by the U.S. Food and Drug Administration. The eyedrops, which are called Betagan, worked well in 72 percent of patients who used them during test studies and have fewer side effects than currently used twice-a-day glaucoma drops. The new drug was developed by Allergan Pharmaceuticals of Irvine, Calif., and can be obtained only by a doctor's prescription.

Baxter International Inc. won Food and Drug Administration clearance to sell the first fibrin sealant approved in the U.S. to help stop bleeding in surgery patients. Baxter's Tisseel is a kind of biological glue. It mimics the body's natural process in blood clotting and can be used to help stymie the flow of blood in patients "when conventional surgical techniques are not feasible," the FDA said.

The Food and Drug Administration asked Congress to give it greater authority to act against generic drug companies that violate drug testing procedures or try to bribe federal officials. The proposed legislation would let the FDA suspend generic drug sales and impose stiff civil penalties on trespassing generic drug companies. It would also let the FDA bar generic drug companies and individuals from applying to the agency for drug approvals after violating testing laws.

TB drug approval: The Food and Drug Administration has approved the first new tuberculosis drug in 25 years. The FDA said that it has approved rifapentine, which is marketed under the name Priftin by Hoechst Marion Roussel Inc. of Kansas City, Mo. The United States is the first country to approve the drug. An advisory panel voted 10-1 to recommend approval earlier this month for the drug, which can cut significantly the number of pills a patient has to take.

Food and Drug Administration investigators are looking into possible brand-name drug manufacturing problems at an Indianapolis plant owned by Eli Lilly & Co. Disclosure of the FDA investigation of Lilly came as the federal agency broadened its separate investigation of the generic drug industry. Officials of some generic drug companies have admitted to engaging in bribery, submission of false data and other criminal activities to get their drugs on the market ahead of competitors` products.

Abbott Laboratories declined to comment Tuesday on reports that the Food and Drug Administration is considering lifting its 20-year-old ban on cyclamates, the artificial sweeteners of which Abbott was a major producer. "We have not had any direct confirmation yet of a reapproval." The FDA said Tuesday that "important issues remain to be resolved and any action will probably not be this year."

Abbott Laboratories applied for Food and Drug Administration permission to market Sevorane, an inhalation anesthetic for inpatient and outpatient surgery. Studies indicate that the drug provides smooth and rapid anesthesia and fast emergence and recovery, said Clair Callan, vice president of Abbott. Sevorane (the trade name for sevoflurane) has been used on 2 million patients in Japan, where it became available last year. Abbott licensed the product from Maruishi of Japan.